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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enteroscope and accessories
510(k) Number K183032
Device Name FUJIFILM Double Balloon Endoscope EI580BT
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader Vader
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
81 Hartwell Avenue
Lexington,  MA  02421
Correspondent Contact Jeffrey Wan
Regulation Number876.1500
Classification Product Code
FDA  
Subsequent Product Codes
FDF   FDS  
Date Received11/01/2018
Decision Date 06/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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